TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program - Full Text View

Purpose

The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.

Condition	Intervention	Phase
Cardiovascular Disease de Novo Coronary Lesions	Device: TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TAXUS ARRIVE 2: A Multi-Center Safety Surveillance Program

Resource links provided by NLM:

Drug Information available for: Paclitaxel

U.S. FDA Resources

Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:

Rate of TAXUS stent related cardiac events as classified by the Clinical Events Committee (CEC). [ Time Frame: 1-year post-implant procedure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rate of TAXUS stent related cardiac events as classified by the CEC. [ Time Frame: within 30 days, 6 months and 2 years ] [ Designated as safety issue: Yes ]
Rate of target vessel related cardiac events as classified by the CEC. [ Time Frame: 30 days, at 6 months, at 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]
Rate of other TAXUS related events [ Time Frame: 30 days, 6 months, 1 and 2 years post-implant procedure ] [ Designated as safety issue: Yes ]

Enrollment:	5016
Study Start Date:	October 2004
Study Completion Date:	July 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Intervention Details:

Drug Eluting Stent used to treat de novo coronary artery lesions.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Appropriate Patient Criteria:

Patient is eligible to receive a Boston Scientific TAXUS Stent

Inappropriate Patient Criteria:

Known sensitivity to paclitaxel.
Known allergy to stainless steel.
Patients in whom antiplatelet and / or anticoagulant therapy is contraindicated.
Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device.
Patients with unresolved vessel thrombus at the lesion site.
Patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm.
Patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation.
Patients with diffuse disease or poor overflow distal to the identified lesions.
Patients with tortuous vessels in the region of the obstruction or proximal to the lesion.
Patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569751

Show 53 Study Locations

Sponsors and Collaborators

Boston Scientific Corporation

Investigators

Study Director:	Eileen Rose, MS	Boston Scientific Corporation
Principal Investigator:	John M Lasala, MD, PhD	Washington University School of Medicine
Principal Investigator:	David A. Cox, MD	Lehigh Valley Physician Group

More Information

No publications provided by Boston Scientific Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Brilakis ES, Lasala JM, Cox DA, Berger PB, Bowman TS, Starzyk RM, Dawkins KD. Outcomes after implantation of the TAXUS paclitaxel-eluting stent in saphenous vein graft lesions: results from the ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program. JACC Cardiovasc Interv. 2010 Jul;3(7):742-50.

Lasala JM, Cox DA, Dobies D, Baran K, Bachinsky WB, Rogers EW, Breall JA, Lewis DH, Song A, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS; ARRIVE 1 and ARRIVE 2 Participating Physicians. Drug-eluting stent thrombosis in routine clinical practice: two-year outcomes and predictors from the TAXUS ARRIVE registries. Circ Cardiovasc Interv. 2009 Aug;2(4):285-93. Epub 2009 Jul 22.

Lasala JM, Cox DA, Lewis SJ, Tadros PN, Haas RC, Schweiger MJ, Chhabra A, Untereker WJ, Starzyk RM, Mascioli SR, Dawkins KD, Baim DS. Expanded use of the TAXUS Express Stent: two-year safety insights from the 7,500 patient ARRIVE Registry programme. EuroIntervention. 2009 May;5(1):67-77.

Responsible Party:	Kellie Windle, Clinical Project Manager, Boston Scientific
ClinicalTrials.gov Identifier:	NCT00569751 History of Changes
Other Study ID Numbers:	S2200
Study First Received:	December 6, 2007
Last Updated:	September 25, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:

de novo
coronary
coronary artery disease
coronary disease

Additional relevant MeSH terms:

Cardiovascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013